Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Proposed Rules 55755 

(2) Class I for tubing and tubing/filter 

kits which include accessory 

instruments that are not used to effect 

intra-abdominal insufflation 

(pneumoperitoneum). The devices 

subject to this paragraph (b)(2) are 

exempt from the premarket notification 

procedures in subpart E of part 807 of 

this chapter, subject to the limitations in 

§ 884.9. If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, the exemption 

from premarket notification does not 

apply and the manufacturer must 

submit a premarket notification that 

includes validation data as described in 

§ 807.3(v). 

59. Section 884.4530 is amended by 

revising paragraph (b)(2) to read as 

follows: 

§ 884.4530 Obstetric-gynecologic 

specialized manual instrument. 

* * * * * 

(b) * * * 

(2) Class I for the amniotome, uterine 

curette, cervical dilator (fixed-size 

bougies), cerclage needle, intrauterine 

device (IUD) remover, uterine sound, 

and gynecological biopsy forceps. The 

devices subject to this paragraph (b)(2) 

are exempt from the premarket 

notification procedures in subpart E of 

part 807 of this chapter, subject to the 

limitations in § 884.9. If the device is a 

gynecological biopsy forceps that is a 

reprocessed single use device (SUD) as 

defined in § 807.3(u) of this chapter, the 

exemption from premarket notification 

does not apply and the manufacturer 

must submit a premarket notification 

that includes validation data as 

described in § 807.3(v). 

60. Section 884.6100 is amended by 

revising paragraph (b) to read as follows: 

§ 884.6100 Assisted reproduction needles. 

* * * * * 

(b) Classification. Class II (special 

controls) (mouse embryo assay 

information, endotoxin testing, 

sterilization validation, design 

specifications, labeling requirements, 

biocompatibility testing, and clinical 

testing). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, the exemption 

from premarket notification does not 

apply and the manufacturer must 

submit a premarket notification that 

includes validation data as described in 

§ 807.3(v). 

PART 886—OPTHALMIC DEVICES 

61. The authority citation for 21 CFR 

part 886 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

62. Section 886.4350 is amended by 

revising paragraph (b) to read as follows: 

§ 886.4350 Manual ophthalmic surgical 

instrument. 

* * * * * 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter, 

subject to the limitations in § 886.9. If 

the device is an ophthalmic knife that 

is a reprocessed single use device (SUD) 

as defined in § 807.3(u) of this chapter, 

the exemption from premarket 

notification does not apply and the 

manufacturer must submit a premarket 

notification that includes validation 

data as described in § 807.3(v). 

63. Section 886.4370 is amended by 

revising paragraph (b) to read as follows: 

§ 886.4370 Keratome. 

* * * * * 

(b) Classification. Class I (general 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

64. Section 886.4670 is amended by 

revising paragraph (b) to read as follows: 

§ 886.4670 Phacofragmentation system. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a 

phacoemulsification needle that is a 

reprocessed single use device (SUD) as 

defined in § 807.3(u) of this chapter, a 

premarket notification submission for 

the device must include validation data 

as described in § 807.3(v). 

PART 892—RADIOLOGY DEVICES 

65. The authority citation for 21 CFR 

part 892 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

66. Section 892.5730 is amended by 

revising paragraph (b) to read as follows: 

§ 892.5730 Radionuclide brachytherapy 

source. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is an isotope 

needle that is a reprocessed single use 

device (SUD) as defined in § 807.3(u) of 

this chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

Dated: September 6, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–8165 Filed 9–22–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[COTP San Francisco Bay 06–036] 

RIN 1625–AA00 

Safety Zone; Red Bull Air Show 

Practice, San Francisco Bay, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes a 

safety zone to be used to keep spectator 

vessels out of the path and away from 

the area directly below participating 

aircraft during the fleet week air show 

practice in order to ensure the safety of 

event participants and spectators. 

DATES: Comments and related material 

must reach the Coast Guard on or before 

October 10, 2006. 

ADDRESSES: You may mail comments 

and related material to the Waterways 

Safety Branch, U.S. Coast Guard Sector 

San Francisco, 1 Yerba Buena Island, 

San Francisco, California 94130. The 

Waterways Safety Branch maintains the 

public docket for this rulemaking. 

Comments and material received from 

the public, as well as documents 

indicated in this preamble as being 

available in the docket, will become part 

of this docket and will be available for 

inspection or copying at the Waterways 

Safety Branch between 9 a.m. and 4 

p.m., Monday through Friday, except 

Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Ensign Erin Bastick, U.S. Coast Guard 

Sector San Francisco, at (415) 556–2950 

or Sector San Francisco 24 hour 

Command Center at (415) 399–3547. 

SUPPLEMENTARY INFORMATION: 

Request for Comments 

We encourage you to participate in 

this rulemaking by submitting 

comments and related material. If you 

do so, please include your name and 

address, identify the docket number for 

this rulemaking (COTP San Francisco 

Bay 06–036), indicate the specific 

section of this document to which each 

comment applies, and give the reason 

for each comment. Please submit all 

comments and related material in an 

unbound format, no larger than 81⁄2 by 

11 inches, suitable for copying. If you 

would like to know they reached us, 

please enclose a stamped, self-addressed 

postcard or envelope. We will consider 

all comments and material received 

during the comment period. We may 


cprice-sewell on PROD1PC66 with PROPOSALS
55756 Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Proposed Rules 

change this proposed rule in view of 

them. 

Public Meeting 

We do not now plan to hold a public 

meeting. But you may submit a request 

for a meeting by writing to the 

Waterways Safety Branch at the address 

under ADDRESSES explaining why one 

would be beneficial. If we determine 

that one would aid this rulemaking, we 

will hold one at a time and place 

announced by a separate notice in the 

Federal Register. 

Background and Purpose 

On October 1, 1993, the Coast Guard 

published a final rule (58 FR 51242) 

modifying the regulations in 33 CFR 

100.1105, that establish regulated areas 

to ensure the safe execution of the San 

Francisco Bay Navy Fleet Week Parade 

of Ships and Air Show Demonstration. 

The U.S. Navy and City of San 

Francisco are sponsoring the Annual 

Fleet Week Parade of Navy Ships and 

Air Show Demonstration to be held 

October 5 thru October 8, 2006. The Red 

Bull practice will be held on October 4, 

2006 from 10 a.m. through 2 p.m., in 

order to allow sufficient time to practice 

prior to the scheduled Fleet Week Air 

Show Demonstration. 

Due to the safety concerns associated 

with the air show practice 

demonstration, this safety zone is 

necessary to provide for the safety of 

event participants, spectator craft, and 

other vessels transiting the event area. 

Discussion of Proposed Rule 

The safety zone will include all 

navigable waters, from the surface to the 

seafloor, encompassed by connecting 

the following points to form an 

approximate square security zone, 

beginning at 37°48′29.50′′ N, 

122°26′34.08′′ W, thence 37° 48′29.32′′ 

N, 122°26′28.65′′ W, thence 37°48′24.95′′ 

N, 122°26′25.25′′ W, thence 37°48′31.24′′ 

N, 122°25′38.66′′ W, thence 37°48′37.96′′ 

N, 122°25′33.80′′ W, thence 37°48′40.70′′ 

N, 122°25′24.74′′ W, thence 37°48′51.90′′ 

N, 122°25′24.79′′ W, lastly to 

37°48′49.14′′ N, 122°26′34.08′′ W. 

No person or vessel may enter or 

remain within the safety zone unless 

authorized by the Captain of the Port 

(COTP), Sector San Francisco, or his 

designated representative. The Coast 

Guard may be assisted by other Federal, 

State, or local law enforcement agencies 

in enforcing this safety zone. 

Because this safety zone will be in 

effect for a limited period, it should not 

result in a significant disruption to 

maritime traffic. Additionally, the 

maritime community will be provided 

advance notification of these events via 

public broadcast notice to mariners. 

Regulatory Evaluation 

This proposed rule is not a 

‘‘significant regulatory action’’ under 

section 3(f) of Executive Order 12866, 

Regulatory Planning and Review, and 

does not require an assessment of 

potential costs and benefits under 

section 6(a)(3) of that Order. The Office 

of Management and Budget has not 

reviewed it under that Order. 

We expect the economic impact of 

this proposed rule to be so minimal that 

a full Regulatory Evaluation is 

unnecessary. 

Although this safety zone restricts 

access to a portion of the navigable 

waters, the effect of this zone will not 

be significant because: (i) The zone 

encompasses only a small portion of the 

waterway; (ii) vessels are able to pass 

safely around the zone; and (iii) the 

practice is a short duration in time, 

lasting only 4 hours. 

The size of the zone is the minimum 

necessary to provide adequate 

protection for personnel or vessels 

during live fire training. The entities 

most likely to be affected are pleasure 

craft engaged in recreational activities 

and sightseeing and commercial fishing 

vessels. 

Small Entities 

Under the Regulatory Flexibility Act 

(5 U.S.C. 601–612), we have considered 

whether this proposed rule would have 

a significant economic impact on a 

substantial number of small entities. 

The term ‘‘small entities’’ comprises 

small businesses, not-for-profit 

organizations that are independently 

owned and operated and are not 

dominant in their fields, and 

governmental jurisdictions with 

populations of less than 50,000. 

The Coast Guard certifies under 5 

U.S.C. 605(b) that this proposed rule 

will not have a significant economic 

impact on a substantial number of small 

entities. Although this safety zone 

prevents traffic from transiting a portion 

of San Francisco Bay during the air 

show practice, the effect of this zone 

will not be significant because small 

vessels will be able to transit around the 

regulated area and the duration of the 

safety zone is limited to four hours in 

length. The entities most likely to be 

affected are pleasure craft engaged in 

recreational activities and sightseeing. 

Small entities and the maritime 

public will also be advised of this safety 

zone via public broadcast notice to 

mariners. In addition, vessels will be 

able to pass through the zone on a caseby-case basis. Therefore, the economic 

impact of this waterway closure is not 

expected to be significant. 

If you think that your business, 

organization, or governmental 

jurisdiction qualifies as a small entity 

and that this rule would have a 

significant economic impact on it, 

please submit a comment (see 

ADDRESSES) explaining why you think it 

qualifies and how and to what degree 

this rule would economically affect it. 

Assistance for Small Entities 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we want to assist small entities in 

understanding this proposed rule so that 

they can better evaluate its effects on 

them and participate in the rulemaking. 

If the rule would affect your small 

business, organization, or governmental 

jurisdiction and you have questions 

concerning its provisions or options for 

compliance, please contact the 

Waterways Safety Branch at the address 

under ADDRESSES. The Coast Guard will 

not retaliate against small entities that 

question or complain about this rule or 

any policy or action of the Coast Guard. 

Collection of Information 

This proposed rule would call for no 

new collection of information under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). 

Federalism 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on State or local governments and 

would either preempt State law or 

impose a substantial direct cost of 

compliance on them. We have analyzed 

this proposed rule under that Order and 

have determined that it does not have 

implications for federalism. 

Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 or more in any one year. 

Though this proposed rule would not 

result in such an expenditure, we do 

discuss the effects of this rule elsewhere 

in this preamble. 

Taking of Private Property 

This proposed rule would not effect a 

taking of private property or otherwise 

have taking implications under 

Executive Order 12630, Governmental 


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Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Proposed Rules 55757 

Actions and Interference with 

Constitutionally Protected Property 

Rights. 

Civil Justice Reform 

This proposed rule meets applicable 

standards in sections 3(a) and 3(b)(2) of 

Executive Order 12988, Civil Justice 

Reform, to minimize litigation, 

eliminate ambiguity, and reduce 

burden. 

Protection of Children 

We have analyzed this proposed rule 

under Executive Order 13045, 

Protection of Children from 

Environmental Health Risks and Safety 

Risks. This rule is not an economically 

significant rule and would not create an 

environmental risk to health or risk to 

safety that might disproportionately 

affect children. 

Indian Tribal Governments 

This proposed rule does not have 

tribal implications under Executive 

Order 13175, Consultation and 

Coordination with Indian Tribal 

Governments, because it would not have 

a substantial direct effect on one or 

more Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes. 

Energy Effects 

We have analyzed this proposed rule 

under Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use. We have 

determined that it is not a ‘‘significant 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

U.S.C. 272 note) directs agencies to use 

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This proposed rule does not use 

technical standards. Therefore, we did 

not consider the use of voluntary 

consensus standards. 

Environment 

We have analyzed this proposed rule 

under Commandant Instruction 

M16475.lD and Department of 

Homeland Security Management 

Directive 5100.1, which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969 

(NEPA)(42 U.S.C. 4321–4370f), and 

have made a preliminary determination 

that there are no factors in this case that 

would limit the use of a categorical 

exclusion under section 2.B.2 of the 

Instruction. Therefore, we believe that 

this rule should be categorically 

excluded, under figure 2–1, paragraph 

(34)(g), of the Instruction, from further 

environmental documentation. 

A final ‘‘Environmental Analysis 

Check List’’ and a final ‘‘Categorical 

Exclusion Determination’’ will be 

available in the docket where indicated 

under ADDRESSES. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard proposes to 

amend 33 CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. 

Chapter 701; 50 U.S.C. 191; 33 CFR 1.05–1(g), 

6.04–1, 6.04–6, and 160.5; Pub. L. 107–295, 

116 Stat. 2064; Department of Homeland 

Security Delegation No. 0170.1. 

2. Add § 165.T11–144 to read as 

follows: 

§ 165.T11–144 Safety Zone; Red Bull Air 

Show Practice, San Francisco Bay, CA. 

(a) Location. The safety zone will 

include all navigable waters, from the 

surface to the seafloor, encompassed by 

connecting the following points to from 

an approximate square security zone, 

beginning at 37°48′29.50′′ N, 

122°26′34.08′′ W, thence 37°48′29.32′′ N, 

122°26′28.65′′ W, thence 37°48′24.95′′ N, 

122°26′25.25′′ W, thence 37°48′31.24′′ N, 

122°25′38.66′′ W, thence 37°48′37.96′′ N, 

122°25′33.80′′ W, thence 37°48′40.70′′ N, 

122°25′24.74′′ W, thence 37°48′51.90′′ N, 

122°25′24.79′′ W, lastly to 37°48′49.14′′ 

N, 122°26′34.08′′ W. 

(b) Definitions. As used in this 

section: (1) Designated representative 

means a commissioned, warrant, or 

petty officer of the Coast Guard who has 

been designated by the Captain of the 

Port (COTP), Coast Guard Sector San 

Francisco, or a Federal, State, and local 

officer designated by or assisting the 

COTP in the enforcement of the safety 

zone. 

(2) [Reserved] 

(c) Regulations. (1) Under the general 

regulations in § 165.23, entry into, 

transiting, or anchoring within this 

safety zone is prohibited unless 

authorized by the COTP or his 

designated representative. 

(2) Vessel operators desiring to enter 

or operate within the safety zone may 

contact the COTP or his representative 

at telephone number 415–399–3547 or 

on VHF–FM channel 16 (156.8 MHz). 

Vessel operators given permission to 

enter or operate in the safety zone must 

comply with all directions given to 

them by the COTP or his designated 

representative. 

(d) Enforcement and suspension of 

enforcement of certain safety zones. The 

COTP will provide notice of the 

enforcement of the safety zones listed in 

paragraph (a) of this section and notice 

of suspension of enforcement by the 

means appropriate to affect the widest 

publicity, including broadcast notice to 

mariners and publication in the local 

notice to mariners. 

(e) Effective period. This section is 

effective October 4, 2006 from 10 a.m. 

through 2 p.m. 

Dated: September 8, 2006. 

W. J. Uberti, 

Captain, U.S. Coast Guard, Captain of the 

Port, San Francisco, California. 

[FR Doc. 06–8134 Filed 9–22–06; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF TRANSPORTATION 

Pipeline and Hazardous Materials 

Safety Administration 

49 CFR Parts 171, 172, 173, 175, 177, 

178, and 180 

[Docket No. PHMSA–05–21812 (HM–218D)] 

RIN 2137–AE10 

Hazardous Materials; Miscellaneous 

Amendments 

AGENCY: Pipeline and Hazardous 

Materials Safety Administration 

(PHMSA), DOT. 


cprice-sewell on PROD1PC66 with PROPOSALS